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Study on ABBV-400 with Fluorouracil, Folinic Acid, and Bevacizumab for Adults with Unresectable Metastatic Colorectal Cancer

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer called unresectable metastatic colorectal cancer. This is a condition where cancer that started in the colon or rectum has spread to other parts of the body and cannot be removed with surgery. The study is testing a new treatment combination to see how safe and effective it is for people who have already received other treatments for this cancer.

The treatment being tested includes a new drug called ABBV-400, which is an antibody-drug conjugate. This means it is a special type of medicine that combines an antibody with a drug to target cancer cells more precisely. ABBV-400 is given together with three other medications: Fluorouracil, Folinic Acid, and Bevacizumab. These medications are already used in cancer treatment and are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to find the best dose of ABBV-400 when used with the other medications and to evaluate how well this combination works in treating the cancer. Participants in the study will receive these treatments over a period of up to 36 weeks. Some participants may receive a placebo instead of ABBV-400 to help researchers compare the effects. The study will monitor participants for any side effects and changes in their cancer to determine the safety and effectiveness of the treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, participation begins with an initial assessment to confirm eligibility. This includes a diagnosis of unresectable metastatic colorectal cancer and measurable disease according to specific criteria.

  2. Step 2

    Treatment initiation

    The treatment phase involves receiving a combination of medications through intravenous infusion. These medications include fluorouracil, irinotecan, bevacizumab, folinic acid, and ABBV-400.

    The specific dosage and frequency of administration are determined by the study protocol, aiming to find the optimal dose of ABBV-400 in combination with the other drugs.

  3. Step 3

    Monitoring and assessments

    Throughout the study, regular monitoring and assessments are conducted to evaluate the response to treatment. This includes measuring disease activity and checking for any adverse effects.

    The primary focus is on objective response and progression-free survival, as assessed by the investigator.

  4. Step 4

    Ongoing evaluation

    Secondary evaluations include the duration of response, overall survival, and best overall response. These assessments help determine the effectiveness and safety of the treatment regimen.

  5. Step 5

    Completion of study

    The study is estimated to conclude by October 2026. At the end of the study, final assessments are made to determine the overall outcomes and any long-term effects of the treatment.

Who can join the trial?

5 criteria

  • Must have a diagnosis of **unresectable metastatic colorectal cancer**. This means the cancer has spread to other parts of the body and cannot be removed by surgery.
  • Must have a **measurable disease** according to specific guidelines called RECIST v1.1. This means the cancer can be measured in size using medical imaging.
  • Must be within the age range of adults, typically 18 years and older.
  • Both **male and female** participants are eligible.
  • Participants from vulnerable populations, such as those who may need special protection, are also eligible.

Who cannot join the trial?

7 criteria

  • Patients who have a different type of cancer other than colorectal cancer cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not able to safely receive the study medications cannot participate.
  • Patients who have certain medical conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are unable to follow the study procedures cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible.
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Investigated drugs

  • ABBV-400

    is an investigational medication being studied for its potential to treat colorectal cancer that cannot be surgically removed and has spread to other parts of the body. The trial aims to find the best dose of ABBV-400 when used in combination with other cancer treatments.

  • Fluorouracil

    is a chemotherapy medication used to treat various types of cancer, including colorectal cancer. It works by interfering with the growth and spread of cancer cells in the body.

  • Folinic Acid

    is often used in combination with other chemotherapy drugs to enhance their effectiveness. It helps protect healthy cells from the harmful effects of chemotherapy and supports the action of fluorouracil.

  • Bevacizumab

    is a medication that targets and inhibits a protein called vascular endothelial growth factor (VEGF). By blocking VEGF, bevacizumab helps prevent the growth of new blood vessels that tumors need to grow and spread. It is used in combination with other cancer treatments to improve their effectiveness.

What is already known about the treatment

  • ABBV-400

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating colorectal cancer. It is in the experimental phase, with ongoing research to determine its optimal dosage and safety profile. ABBV-400 is being tested in combination with other drugs like fluorouracil, folinic acid, and bevacizumab. Its mechanism of action involves targeting specific cancer cells to inhibit their growth. ABBV-400 is classified as an investigational drug, and its use is primarily within the context of clinical research.

  • Fluorouracil

    This medication is administered intravenously and is widely used in the treatment of various cancers, including colorectal cancer. It is well-established in medical literature as a chemotherapy agent. Fluorouracil works by interfering with the DNA synthesis of cancer cells, thereby preventing their growth and division. It is classified as an antimetabolite, a type of chemotherapy drug.

  • Folinic Acid

    Administered intravenously, folinic acid is used in combination with other chemotherapy drugs to enhance their effectiveness, particularly in colorectal cancer treatment. It is well-documented in medical literature as a supportive therapy. Folinic acid works by stabilizing the binding of fluorouracil to its target enzyme, enhancing the drug's cancer-fighting effects. It is classified as a chemoprotective agent.

  • Bevacizumab

    This medication is administered intravenously and is used in the treatment of various cancers, including colorectal cancer. It is well-established in medical literature as a targeted therapy. Bevacizumab works by inhibiting the growth of blood vessels that supply nutrients to tumors, effectively starving the cancer cells. It is classified as a monoclonal antibody and an angiogenesis inhibitor.

Investigated diseases

Colorectal Cancer – Colorectal cancer is a type of cancer that begins in the colon or rectum, parts of the large intestine. It typically starts as small, noncancerous clumps of cells called polyps that form on the inside of the colon or rectum. Over time, some of these polyps can become cancerous. As the cancer progresses, it can invade and destroy normal tissue nearby and may spread to other parts of the body. The progression of colorectal cancer can vary, with some cases growing slowly over several years. Early stages may not show symptoms, but as it advances, symptoms like changes in bowel habits, blood in the stool, and abdominal discomfort may occur.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-505110-14-00Protocol codeM24-311Estimated enrolment206 patientsSponsorAbbVie Deutschland GmbH & Co. KG

sourced from the EU Clinical Trials Register and site verification

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